A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction

NCT03776162 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: G180167R01AR074131-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-55 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years.

Conditions

Anterior Cruciate Ligament Tear

Keywords

Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Reconstruction; Anterior Cruciate Ligament Repair; Knee Surgery

Outcome Measures

Primary Outcomes (2)

• KT-1000

  Co-primary Outcome measure: Knee stability or the antero-posterior (AP) knee laxity will be determined using a KT-1000 arthrometer at the 30lb force setting on both knees of the subject at 6 months, 1 and 2 years after surgery. The primary endpoint will be 2 year KT-1000. Both left and right knees will be covered with a sleeve so the trained examiner cannot tell which the operated knee is or which procedure the patient had. Values for both knees will be recorded. For knee laxity 2.5 mm in the side-to-side difference measurements will be taken as the non-inferiority margin for the 2 year post-operative comparison of patients in the bridge-enhanced repair group and the ACL reconstruction groups.Testing will be performed by experienced, certified athletic trainers, physical therapists or physician assistants trained using standardized equipment according to the MOON protocol.

  KT-1000 instrumented knee laxity measure 2 years after surgery (difference from contralateral knee)

• IKDC (International Knee Documentation Committee) Score

  The IKDC patient-reported outcome measure instrument will be completed by patients pre-operatively, then at 3 and 6 months, 1 year and at the final 2 year visit after surgery. The primary endpoint will be evaluated at 2 years. The IKDC non-inferiority margin for BEAR vs. autograft patellar tendon will be set at \<16 points. The IKDC is a patient reported outcome measure which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  Validated Patient Reported IKDC Subjective Score Instrument 2 years after surgery (change from baseline)

Secondary Outcomes (9)

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Validated Patient Reported KOOS Subjective Score Instrument 2 years after surgery

• MARX Activity (Marx Activity Rating Scale)

  MARX Activity 2 years after surgery

• Anterior Knee Pain Scale (AKPS)

  AKPS 2 years after surgery

• Quadriceps Strength Testing

  Quadriceps Strength 2 years after surgery

• Hop Test Limb Difference

  Hop Test Limb Difference 2 years after surgery

Study Arms (2)

ACL Reconstruction(BPTB Graft)

ACTIVE COMPARATOR

Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

Procedure: ACL Reconstruction (Bone Patellar Tendon Bone Graft)

Bridge Enhanced ACL Restoration

EXPERIMENTAL

Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Device: Bridge Enhanced ACL Restoration (BEAR)

Interventions

ACL Reconstruction (Bone Patellar Tendon Bone Graft) PROCEDURE

Standard of care procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

ACL Reconstruction(BPTB Graft)

Bridge Enhanced ACL Restoration (BEAR) DEVICE

The BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Bridge Enhanced ACL Restoration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• years of age
• Complete ACL tear as confirmed by MRI
• Selected surgical treatment of ACL injury
• Believed to be a surgical candidate for ACL reconstruction by treating physician
• Time from injury to surgery is ≤50 days
• Stated willingness to comply with all study procedures for the duration of the study, including lifestyle, activity, and sports restrictions
• Provision of signed and dated informed consent form

You may not qualify if:

• An individual who meets any of the following criteria, either during a pre-operative exam or during intraoperative arthroscopic evaluation, will be excluded from participation in this study:
• Any prior ACL surgery on affected knee (except simple arthroscopy for plica, debris removal, or diagnosis)
• Any prior ACL surgery on unaffected knee (except simple arthroscopy for plica, debris removal, diagnosis or partial meniscectomy)
• Confirmed or suspected contralateral ACL tear
• ACL tear found to be only partial and the treating physician feels it does not require surgery because it is "stable"
• Diagnosis of posterolateral corner injury (complete lateral collateral ligament tear, biceps femoris tendon avulsion, arcuate ligament tear, popliteus ligament tear) that requires concurrent or staged surgical treatment
• Diagnosis of Grade III medial collateral injury that requires concurrent or staged surgery
• Insufficient ACL tissue on MRI
• Diagnosis of complete patellar dislocation
• Diagnosis of complete patellar tendon or quadriceps tear
• Obesity with a BMI ≥45
• Does not speak or understand English
• Daily smoking (occasional or social use is accepted if smoking ≤ 3 days/ week and ≤ 5 cigarettes/day)
• Documented history of illicit drug or alcohol abuse (except for recreational use of marijuana)
• Inability to take oral medications

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Miach Orthopaedics: collaborator

Study Sites (6)

University of Colorado

Boulder, Colorado, 80309, United States

Location

TRIA Orthopaedics Center/ University of Minnesota

Bloomington, Minnesota, 55431, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43202, United States

Location

University Orthopedics Institute/ Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• BEAR-MOON; Vega JF, Strnad GJ, Briskin I, Cox CL, Farrow LD, Fadale P, Flanigan D, Hulstyn M, Imrey PB, Kaeding CC, Owens BD, Saluan P, Wright R, Yen YM, Spindler KP. Interrater Agreement of an Arthroscopic Anterior Cruciate Ligament Tear Classification System. Orthop J Sports Med. 2020 Dec 3;8(12):2325967120966323. doi: 10.1177/2325967120966323. eCollection 2020 Dec.

  PMID: 33330736 BACKGROUND

• BEAR-MOON Design Group; Spindler KP, Imrey PB, Yalcin S, Beck GJ, Calbrese G, Cox CL, Fadale PD, Farrow L, Fitch R, Flanigan D, Fleming BC, Hulstyn MJ, Jones MH, Kaeding C, Katz JN, Kriz P, Magnussen R, McErlean E, Melgaard C, Owens BD, Saluan P, Strnad G, Winalski CS, Wright R. Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial. Orthop J Sports Med. 2022 Jan 25;10(1):23259671211065447. doi: 10.1177/23259671211065447. eCollection 2022 Jan.

  PMID: 35097143 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Kurt P Spindler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Treatment will be determined by intra-operative computer-generated randomization after the diagnostic arthroscopy and participant treatment assignment will not be reported to the participant until termination of the study observation period. Research Assessments by Independent Blinded Assessor for assessments of study endpoints and safety. KT-1000 knee laxity arthrometer testing, International Knee Documentation Committee (IKDC) patient-reported outcome score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Marx knee activity rating scale, Anterior Knee Pain Scale, Quadriceps Strength, Hop testing, and physical examination. The physical therapist implementing the post-surgical rehabilitation will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Surgery CCLCM Case Western, Director Research and Outcomes Cleveland Clinic Florida, Director Outcomes Management Evaluation, Co-Director Musculoskeletal Research Center

Model Details: Multi-center, 2-arm, 1:1 permuted block randomized controlled clinical trial, with a blinded patient and outcome assessor.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: August 30, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Per National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) policy, 2 years after posting of study results.
• Access Criteria: This study will comply with the NIH Data Sharing Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Locations

US (6)